The FLEX-MATE K500 is a continuous passive motion (CPM) device designed to provide therapeutic movement to the knee or hip joint. Its primary functions are to increase circulation, improve range of motion, and prevent scarring in the joint. The device is anatomically aligned to mirror the natural path of the knee, moving from full or hyper-extension through full flexion.
Important Safeguards and Warnings:
Users must read all instructions and warnings prior to operation. To reduce the risk of electrocution, the device should always be unplugged immediately after use, never used while bathing, and kept away from water. If the product falls into water, it should be unplugged immediately. To reduce the risk of burns, electrocution, fire, or injury, the device should never be left unattended when plugged in. Close supervision is necessary when used by or near children or invalids. The device should only be used for its intended purpose as described in the manual, and no unauthorized attachments should be used. Never operate the product if it has a damaged cord or plug, or if it is not working properly, has been dropped, or has been damaged by water; in such cases, it should be returned to a service center for examination and repair. The cord must be kept away from heated surfaces. The device should not be used while sleeping or drowsy, and no objects should be dropped into or inserted into any opening. It should not be used outdoors or where aerosol (spray) products are being used, or where oxygen is being administered. The device must be connected to a properly grounded outlet.
Electromagnetic Interference:
This equipment may cause electromagnetic or other interference with other devices. If this occurs, the device should be moved away from the affected equipment. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Users should work within the range of motion instructed by their healthcare practitioner. If increased pain, swelling, or any adverse reactions are experienced while using the product, a healthcare practitioner should be consulted immediately.
Setup and Usage Environment:
The equipment should be set up and used in a low-traffic location, away from children and pets. Pinch points exist during assembly, so caution is advised, and assembly should be performed according to instructions. The hand control must be accessible to the operator before starting the equipment, as its stop button is the only way to halt motion for disabled patients or children using the unit. The maximum rated load for the device is 45 lbs.
Contraindications:
CPM therapy should generally be avoided or discontinued, at least temporarily, if signs of hyperthermia, irritation, swelling, bleeding, or increased or persistent pain are observed. Acute inflammatory conditions, such as acute arthritis, or destructive bone or joint diseases, should not be treated with CPM. The product is latex-free.
Interference Mitigation:
To prevent harmful interference to other devices, the equipment must be installed and used in accordance with instructions. If interference occurs, users are encouraged to try one or more of the following measures: reorient or relocate the other device(s), increase the separation between the equipment, connect this equipment into an outlet on a circuit different from that to which the other device(s) are connected, or consult the manufacturer or field service technician for help.
Technical Specifications:
- Size (Setup for Use): Length 39", Width 13", Height 22"
- Weight: Without accessories 26 lbs., With accessories 27 lbs., Fully packaged 34 lbs.
- Electrical Specifications: Input 120 VAC 60Hz 25 W
- Environmental Requirements:
- Temperature: Operating 50°F to 95°F (10°C to 35°C), Transport & Storage -40°F to 158°F (-40°C to 70°C)
- Humidity: Operating 30-75% R.H., Transport & Storage 10-100% R.H., non-condensing
- Atmospheric Pressure: 700 hPa to 1060 hPa
- Standards Compliance: Designed to conform to applicable requirements of UL 60601-1, UL 1431, CSA C22.2 / No. 601.1. UL/C-UL Classification with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No. 601.1. Meets UL 1431 Standards for Personal Hygiene and Healthcare Appliances.
Grounding Instructions:
This product must be grounded to reduce the risk of electric shock in the event of a short circuit. It is equipped with a grounding wire and plug, which must be plugged into a properly installed and grounded outlet. Improper use of the grounding plug can result in electric shock. If grounding instructions are not fully understood or if there is doubt about proper grounding, consult a qualified electrician or serviceman. The product is factory-equipped with a specific power supply for connection to a proper electric circuit. Ensure the product is connected to an outlet with the same configuration as the plug. No adapter should be used, and the plug should not be modified. If the plug does not fit the outlet, a qualified electrician should install the proper outlet.
Package Contents:
- 1 FLEX-MATE K500
- 1 Users Manual
- 1 Service Manual
- 1 Package of soft goods
- 1 Tape measure
Set Up Instructions:
- Open the shipping container, set aside the soft goods bag, lift the FLEX-MATE K500 from the box, and place it in the desired location.
- Plug the wall transformer into a 110/120V AC wall outlet. Locate the power switch and press "On." Use the hand-held controller to bring the machine to between 45° and 90°.
- Secure the patient pads to the machine. The Foot Pad slips over the Foot Plate, while the Tibia and Femur Pads have straps that secure to the black Velcro pads.
- Measure the patient's involved leg from the hip joint to the midline of the knee joint. Set the femur scale to this measurement and retighten the knobs.
- Loosen the adjustment knobs on the tibia bars and pull the foot plate out to a length greater than the patient's lower leg.
- Use the hand-held controller to bring the machine to the desired start position.
- Place the patient's leg in the machine, ensuring the patient's knee is aligned with the joint on the machine.
- Adjust the foot plate to meet the patient's foot and tighten the tibia bar knobs.
- Wrap the Pad Strap around the thigh, femur bars, and pad to secure the patient's leg to the FLEX-MATE K500.
- Before starting, follow the Hand-held Controller Operation instructions to set flexion, extension, speed, and pause duration. Run a complete cycle to ensure correct knee alignment. If the knee joint does not mirror the machine joint movement, adjust the femur or tibia bars for proper alignment.
- Plantar/Dorsiflexion: Loosen the adjustment knobs on each side of the foot plate. Adjust the foot plate to the desired degree of plantar or dorsiflexion, then retighten the knobs.
- External/Internal Rotation: Loosen the adjustment knobs on the foot plate. Adjust the foot plate to the prescribed degree of external/internal rotation, then retighten the knobs.
- Remove the adjustment knob on the bottom of the foot plate, then remove the foot plate.
- Loosen the adjustment knobs on each side of the foot plate.
- Rotate the foot plate bracket inward 180°.
- Reattach the foot plate to the foot plate bracket. Adjust for plantar/dorsiflexion and internal/external rotation as needed.
Hospital Bed Fixture (Optional):
The FLEX-MATE K500 Hospital Bed Fixture can be purchased optionally to attach the K500 to a hospital bed. Assemble the fixture to the K500 by sliding it into the tubes at the end of the K500. Screw in and tighten the included knobs. Position the K500 on the bed in the appropriate position and attach it to a bed-mounted traction bar using standard traction fittings. The K500 is not to be carried by the Hospital Bed Fixture.
Hand-held Controller Operation:
Turn on the power switch located at the foot of the machine.
- Range of Motion Set: Hold down "EXT" or "FLEX" and press "UP" or "DOWN" arrow to set the limits. Full range is from -10° extension to 120° flexion.
- Speed Set: Hold down "SPEED" and press "UP" or "DOWN" arrow to set speed. Speed can be adjusted in 10-degree increments ranging from 30° per minute to 150° per minute.
- Pause Set: Hold down "DELAY" and press "UP" or "DOWN" arrow to set the length of time the unit will pause at the flexion and extension limits. Delay range is from 0 seconds to 30 seconds.
- Start/Stop: Press "START/STOP" to begin motion. Press "START/STOP" again to stop motion.
- Setting Lock: Press both "UP" and "DOWN" arrows at the same time to lock the setting, and again to unlock. When locked, a dot will show in the lower right corner of the display. Note: Locking mode is retained even when power is turned off.
Cleaning and Maintenance:
With the unit unplugged, clean the housing and leg carriage with a mild soap solution and dry thoroughly. Refer to the Service Manual for recommended maintenance.
CAUTION: Avoid getting water inside the housing, as it may damage the electrical components.
To Next Page
General